Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Streptococcus Pneumoniae Vaccines

Treatments

Biological: Pneumovax 23™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00307008

513026/004

100436

100421

Details and patient eligibility

About

Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

Full description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Enrollment

1,198 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Subjects who the investigator believes will comply with the requirements of the protocol.
A male or female >= 65 years at the time of the first vaccination.
Written informed consent obtained from the subject.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
Previous vaccination against Streptococcus pneumoniae.
History of administration of an experimental vaccine containing MPL or QS21.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Current serious neurologic or mental disorders.
Inflammatory processes such as known chronic active infections (e.g.Hep B, C).
All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
Acute disease at the time of enrolment.
Chronic disease that might preclude participation to the whole study.